Systems and methods for hernia repair

ABSTRACT

One embodiment of the present invention relates to a minimally invasive implant-based ventral hernia repair system including a first and second elongated member in which the second elongated member extends through the internal channel of the first elongated member. A set of arm members are moveably coupled to the distal end of the first elongated member. A set of tension members extends lengthwise along the arm members and is rigidly coupled between the distal most segment of each arm member and the second elongated member. The degree of tension in the tension members corresponds to the configuration of the arm members with respect to the first elongated member. The proximal translation of the second elongated with respect to the first elongated member causes tension on the tension members, which thereby articulates the arm members into a radial extended configuration in which the arm members extend radially and substantially perpendicular to the first elongated member.

FIELD OF THE INVENTION

The invention generally relates to minimally invasive hernia repairsystems. In particular, the present invention relates to a minimallyinvasive implant-based ventral hernia repair system and method ofoperation.

BACKGROUND OF THE INVENTION

A hernia is a weakness in a particular anatomical surface which allowsan internally contained organ to protrude. Ventral hernias are a type ofhernia resulting primarily from weaknesses in the abdominal wall.Hernias of the groin region, or inguinal hernias, are a separate type ofabdominal wall hernia which are repaired with a different subset ofsurgical equipment and techniques. Repair of ventral hernia defectsconventionally utilized open primary sutured repair. However, recurrencerates of ventral hernias after an open primary suture procedure weredetermined to be unacceptably high. Open mesh repair utilizes asynthetic or biologic mesh to correct the hernia but is still performedas an open invasive procedure. Open mesh repair has recently beenreplaced by laparoscopic, or minimally invasive, mesh repair. Recurrencerates have been shown to be lower after laparoscopic ventral herniarepair with respect to open repair. Laparoscopic type hernia repairreduces dissection and destruction of the structurally important fasciallayers of the abdominal wall via the use of small incisions in thefascia, through which trocars are placed for instrumentation.Unfortunately, even small (i.e. 5 mm) incisions can potentially developinto new hernias, especially in patients with a demonstrated propensityto developing fascial breakdown. Therefore, fewer trocars utilized toperform an operation generally results in a lower recurrence rate.Conventional laparoscopic surgical techniques for ventral hernia repaircommonly require up to six trocars and corresponding incisions forproper manipulation of instruments and mesh implants.

Therefore, there is a need in the industry for systems and methods thatreduce the number of trocars necessary for minimally invasiveimplant-based ventral hernia repair.

SUMMARY OF THE INVENTION

The invention generally relates to minimally invasive hernia repairsystems. One embodiment of the present invention relates to a minimallyinvasive implant-based ventral hernia repair system. The system includesa first elongated member with an internal channel extending between adistal and proximal opening. A second elongated member extends throughthe internal channel of the first elongated member. A set of arm membersis moveably coupled to the distal end of the first elongated member suchthat the arm members have a restricted freedom of movement with respectto the first elongated member. The arm members each include a set oflengthwise moveably intercoupled segments. A set of tension membersextends lengthwise along the arm members and is rigidly coupled betweenthe distal most segment of each arm member and the second elongatedmember. The degree of tension in the tension members corresponds to theconfiguration of the arm members with respect to the first elongatedmember. The proximal translation of the second elongated with respect tothe first elongated member causes tension on the tension members, whichthereby articulates the arm members into a radial extended configurationin which the arm members extend radially and substantially perpendicularto the first elongated member. A mesh is releasably coupled to thedistal side of the arm members to facilitate coupling over thecorresponding hernia. The moveable couplings between the arm members andthe first elongated member and between the intercoupled segments of thearm members facilitates a restricted lengthwise freedom of movement thatenables the system to be coupled to the mesh over the hernia and to beremovable from between the mesh and hernia. A second embodiment of thepresent invention relates to a method of distally coupling a mesh over aventral hernia in the abdominal wall and subsequently removing theremainder of the hernia repair system.

Embodiments of the present invention represent a significant advancementin the field of ventral hernia repair. Conventional minimally invasiveventral hernia repair systems and procedures utilize multipleinstruments and openings in the abdominal wall to position and suture amesh or implant over the hernia. Embodiments of the present inventionprovide a self-contained system for hernia mesh deployment and suturingthrough the hernia opening itself. The unique selectively restrictedmovement freedom of the arm members enables the system to be insertedthrough the internal channel of a trocar, coupled with a mesh over thedistal opening of a hernia, and the remainder removed from between themesh and hernia. This presents an advantage because the number ofabdominal wall openings made in a hernia repair procedure has beendetermined to directly correspond to hernia recurrence rate.

These and other features and advantages of the present invention will beset forth or will become more fully apparent in the description thatfollows and in the appended claims. The features and advantages may berealized and obtained by means of the instruments and combinationsparticularly pointed out in the appended claims. Furthermore, thefeatures and advantages of the invention may be learned by the practiceof the invention or will be obvious from the description, as set forthhereinafter.

BRIEF DESCRIPTION OF THE DRAWINGS

The following description of the invention can be understood in light ofthe Figures, which illustrate specific aspects of the invention and area part of the specification. Together with the following description,the Figures demonstrate and explain the principles of the invention. Inthe Figures, the physical dimensions may be exaggerated for clarity. Thesame reference numerals in different drawings represent the sameelement, and thus their descriptions will be omitted.

FIG. 1 illustrates a perspective view of a hernia repair system andcorresponding trocar in accordance with one embodiment of the presentinvention;

FIG. 2 illustrates an exploded view of the hernia repair systemillustrated in FIG. 1;

FIG. 3 illustrates a detailed perspective view of the distal end of thefirst and second elongated members of the hernia repair systemillustrated in FIG. 1;

FIG. 4 illustrates a detailed perspective view of the arm members andthe distal ends of the first and second elongated members of the herniarepair system illustrated in FIG. 1;

FIGS. 5A-5F illustrate cross-sectional views of the hernia repair systemof FIG. 1 along the corresponding axis A-A′ through F-F′;

FIG. 6 illustrates a detailed perspective view of the distal segment ofa single arm member of the hernia repair system illustrated in FIG. 1;

FIG. 7 illustrates a profile view of the proximal ends of the first andsecond elongated member of the hernia repair system illustrated in FIG.1;

FIG. 8 illustrates a detailed perspective view of the mesh coupled tothe distal side of the arm members of the hernia repair systemillustrated in FIG. 1;

FIGS. 9A-9B illustrate perspective views of the proximal ends of thefirst and second elongated member corresponding to two differentoperational states of the hernia repair system illustrated in FIG. 1;

FIG. 10 illustrates a detailed perspective view of the distal ends ofthe first and second elongated members in an unlocked configuration ofthe hernia repair system illustrated in FIG. 1;

FIG. 11 illustrates a detailed perspective view of the distal ends ofthe first and second elongated members in a locked configuration of thehernia repair system illustrated in FIG. 1;

FIG. 12 illustrates a detailed perspective view of the arm members,mesh, and the distal ends of the first and second elongated members in adistal lengthwise extended, or undeployed configuration of the armmembers of the hernia repair system illustrated in FIG. 1;

FIG. 13 illustrates a detailed perspective view of the arm members,mesh, and the distal ends of the first and second elongated members in aradial extended configuration of the arm members of the hernia repairsystem illustrated in FIG. 1; and

FIG. 14 illustrates a detailed perspective view of the arm members andthe distal ends of the first and second elongated members in a partiallyretracted configuration of the hernia repair system illustrated in FIG.1.

DETAILED DESCRIPTION OF THE INVENTION

The invention generally relates to minimally invasive hernia repairsystems. One embodiment of the present invention relates to a minimallyinvasive implant-based ventral hernia repair system. The system includesa first elongated member with an internal channel extending between adistal and proximal opening. A second elongated member extends throughthe internal channel of the first elongated member. A set of arm membersis moveably coupled to the distal end of the first elongated member suchthat the arm members have a restricted freedom of movement with respectto the first elongated member. The arm members each include a set oflengthwise moveably intercoupled segments. A set of tension membersextends lengthwise along the arm members and is rigidly coupled betweenthe distal most segment of each arm member and the second elongatedmember. The degree of tension in the tension members corresponds to theconfiguration of the arm members with respect to the first elongatedmember. The proximal translation of the second elongated with respect tothe first elongated member causes tension on the tension members, whichthereby articulates the arm members into a radial extended configurationin which the arm members extend radially and substantially perpendicularto the first elongated member. A mesh is releasably coupled to thedistal side of the arm members to facilitate coupling over thecorresponding hernia. The moveable couplings between the arm members andthe first elongated member and between the intercoupled segments of thearm members facilitates a restricted lengthwise freedom of movement thatenables the system to be coupled to the mesh over the hernia and to beremovable from between the mesh and hernia. A second embodiment of thepresent invention relates to a method of distally coupling a mesh over aventral hernia in the abdominal wall and subsequently removing theremainder of the hernia repair system. Also, while embodiments aredescribed in reference to ventral hernia repair, it will be appreciatedthat the teachings of the present invention are applicable to otherareas. For example, embodiments and teachings of the present inventionmay be utilized to repair other types of hernias.

The following terms are defined as follows:

Endoscopic surgery—broadly defined to include all minimally invasivesurgical procedures, including but not limited to laparoscopy,thoracoscopy and arthroscopy.

Hernia—a weakness or recess in a particular anatomical surface whichallows an internally contained organ to protrude. The internal side ofthe herniated surface is referred to herein as the distal side. Theexternal side of the herniated surface is referred to herein as theproximal side. A particular type of hernia referred to as a ventralhernia involves a weakness in the abdominal wall.

Trocar—a cylindrical device which may be inserted through a surgicalincision to provide a channel through a body wall to the intendedinternal surgical region.

Distal—an anatomical surgical reference term used herein to refer to aregion toward the body of the patient. For example, a trocar disposedwithin a patient is oriented such that the distal end is disposed withinthe surgical field and/or the patient's body.

Proximal—an anatomical surgical reference term used herein to refer to aregion away from the body of the patient. For example, a trocar disposedwithin a patient is oriented such that the proximal end is disposedexternal to the patient's body.

Mesh—a general term used to describe any synthetic or biologic implantconfigured to extend over and cover the internal opening/weakness of ahernia.

Needle—a general term used to describe any suture device configured tocouple a mesh over a hernia.

Reference is initially made to FIG. 1, which illustrates a perspectiveview of a hernia repair system and corresponding trocar, designatedrespectively at 100 and 200. Minimally invasive hernia repair proceduresinitially include inserting a trocar through the herniated surface,thereby creating a proximal to distal channel through the hernia in theabdominal wall. The trocar provides an access channel through whichinstruments may be inserted distal to the hernia. Conventionallaparoscopic hernia repair procedures require the insertion ofadditional trocars in the vicinity of the hernia to enable additionalinstruments to access the distal side of the herniated surface.Embodiments of the present invention include a system that is designedto operate exclusively through a single trocar 200 positioned throughthe hernia. The illustrated hernia repair system 100 is configured to beinserted through the internal channel of the trocar 200 onto the distalside of the hernia so as to expand and implant a repair mesh over thehernia. The illustrated trocar 200 is for reference purposes only, andit will be appreciated that the illustrated embodiment may be utilizedwith other trocars.

The hernia repair system 100 includes a first elongated member 120, asecond elongated member 140, a plurality of tension members 210, and aplurality of arm members 180. The illustrated first elongated member 120is cylindrically shaped with a particular external diameter andcurvature corresponding to the diameter of the internal channel of theillustrated trocar 200. It will be appreciated that various diametersand shapes may be utilized in accordance with embodiments of the presentinvention. In addition, the external surface of the first elongatedmember 120 is configured to facilitate a smooth translation within theinternal channel of the trocar 200. The first elongated member 120 isillustrated with a distal end oriented towards the left and a proximalend oriented to the right. The plurality of arm members 180 are moveablycoupled to the distal end of the first elongated member 120. Theplurality of arm members 180 are distally extended and capable of threedimensionally conforming to the diameter of the internal channel of thetrocar 200. The second elongated member 140 is lengthwise extendedthrough the first elongated member 120. The second elongated member 140is illustrated with a distal end towards the left and a proximal endoriented to the right. The operation, assembly, and technicalspecifications of each of the components of the hernia repair system 100will be described further in reference to the subsequent figures.

Reference is next made to FIG. 2, which illustrates an exploded view ofthe hernia repair system 100. The hernia repair system 100 generallyincludes a first elongated member 120, a second elongated member 140, aplurality of arm members 180, and a plurality of tension members 210.The first elongated member 120 includes a cylindrical region 124, aproximal end 122, an internal channel 125, and a distal end 130. Thecylindrical region 124 is an elongated hollow member which may becomposed of a rigid metal material such as stainless steel or aluminum.The cylindrical region 124 is positioned between the proximal and distalends 122, 130 of the first elongated member 120. The internal channel125 extends lengthwise within the cylindrical region 124. The particularexternal shape, diameter, and surface texture of the cylindrical region124 are configured to correspond to the diameter of the internal channelof a trocar. The proximal end 122 includes a dual recess handle shapedregion to facilitate operation. It will be appreciated that varioushandle shapes may be utilized to accommodate different functionalities.The illustrated dual recess shape provides a surface upon which a user'sfingers may oppose a distal or proximal oriented thumb force upon thesecond elongated member 140 with respect to the first elongated member120. The illustrated handle shaped region is coupled to the cylindricalregion via a recess within which the cylindrical region 124 is extended.The handle region may be composed of a rigid plastic composite material.The internal channel 125 extends through the proximal end 122 and handleshaped region to a proximal opening on a proximally oriented surface ofthe proximal end 122. The distal end 130 includes a coupler region 128moveably coupled to the plurality of arm members 180. The coupler region128 includes a plurality of radially oriented recesses 126, a pluralityof radially oriented arm member articulation regions 132, and aplurality of radially oriented spacer regions 134. The internal channel125 extends through the distal end 130 to a distal opening on a distaloriented surface. The plurality of arm members 180 are moveably coupledto the distal end 130 so as to facilitate a restricted freedom ofmovement radially oriented within the arm member articulation regions132. The spacer regions 134 radially space the articulation of the armmembers 180 from one another. The illustrated shape of the distal end issubstantially cylindrical to maintain total system conformity to withinthe diameter of the internal trocar channel in a particular distalextended configuration. A smaller diameter region is positioned betweenthe cylindrical region 124 and the arm member articulation region 132.The smaller diameter region provides a transition region for the tensionmembers 210 to extend between the internal channel 125 and the armmembers 180 without radially extending beyond the diameter correspondingto the internal channel of a trocar 200. The recesses 126 are disposedin the smaller diameter region and extend between the exterior and theinternal channel 125.

The arm members 180 are moveably coupled to the distal end 130 of thefirst elongated member 120 to limit the articulation of the arm members180 between a lengthwise extended distal configuration (FIG. 12) and aradial extended configuration (FIG. 13). The particular coupling betweenthe distal end 130 and the arm members 180 may utilize a pin typeconnection oriented across and through the arm member articulationregions 132 and the arm members 180 so as to facilitate a substantiallylengthwise (proximal to distal) oriented articulation. The shape andpositioning of the pin with respect to the arm members 180 and the armmember articulation regions 132 will restrict the lengthwise freedom ofarticulation of the arm members 180 to within 180 degrees. The armmembers 180 further include a plurality of intercoupled segmentsincluding a proximal segment 182, medial segments 184, and a distalsegment 190. Configuration and specifications of the segments will bedescribed in more detail with reference to subsequent figures. Theintercoupled segments are moveably coupled to one another in aconfiguration that restricts relative lengthwise articulation to within90 degrees between individual segments. The intercoupled segments mayutilize a male region 188, female region 187, and a pin 186 extendingperpendicular as illustrated and described further in reference to FIG.6. The restricted moveable couplings between the distal end 130 and theproximal segment 182, and between the individual segments 182, 184, 190operate to restrict the overall articulation freedom of the arm members180 to between the lengthwise extended distal configuration (FIG. 12)and the radial extended configuration (FIG. 12). Various types ofanalogous restricted moveable coupling schemes may be utilized inaccordance with embodiments of the present invention.

A plurality of tension members 210 are rigidly coupled to and extendingbetween the distal segment 190 of each of the arm members 180 and thesecond elongated member 140. The tension members 210 may be any type oflengthwise substantially flexible member including but not limited tocables, sutures, threads, wires, etc. The tension members extendsubstantially lengthwise along the segments of the arm members 180,through the recesses 126 in the distal end 130 of the first elongatedmember 120 to the internal channel of the first elongated member, andare coupled to the second elongated member 140. The length and relativetension of the tension members 210 corresponds to the configuration ofthe plurality of arm members 180 with respect to the first elongatedmember 120. The tension members 210 extend substantially along thedistal oriented side of the segments of the arm members 180 if the armmembers 180 are positioned in the radially extended configuration (FIG.12). The tension members 210 extend from the recesses 126 through a holeon a proximally oriented side of the proximal segment 182 in the smallerdiameter region of the distal end 130 of the first elongated member 120.The coupling and length of the tension members 210 with respect to thesecond elongated member 140 are configured such that there is no tensionif the proximal end 144 of the second elongated member is adjacent tothe proximal end 122 of the first elongated member 120 (FIG. 7).

With continued reference to FIG. 2, the second elongated member 140includes a proximal end 142, a locking pin 144, a flat region 146, anotch 148, an O-ring 141, a medial region 150, a washer 151, a threadedregion 152, a nut 143, a shaft 156, and a distal end 160. As describedabove, the majority of the second elongated member 140 is disposedwithin the internal channel 125 of the first elongated member 120 duringoperation, with the exception of the proximal and distal ends 142, 160.The proximal end 142 includes a single recess curved handle shapedregion. It will be appreciated that various handle shapes may beutilized to accommodate different functionalities. The illustratedsingle recess shape provides a surface upon which a user's thumb mayexert a distal or proximal oriented thumb force upon the secondelongated member 140 with respect to the first elongated member 120. Theoperational movement between the proximal ends 122, 142 of the first andsecond elongated members 120, 140 is in part analogous to the operationof a syringe. The proximal end 142 is operationally coupled over acorresponding cylindrical portion of the medial region 150 via the pin144. The flat region 146 and notch 148 are shaped to facilitate anoperational locking of the second elongated member 140 in a particularproximally translated and rotated position with respect to the firstelongated member 120 (FIG. 9B). The shape of the flat region 146 andnotch 140 correspond to the shape of the proximal opening to theinternal channel 125 on the proximal end 122 of the first elongatedmember 120. The O-ring 141 is a rubber circular member circumscribingthe medial region 150 to facilitate a smooth operational translationbetween the first and second elongated members 120, 140. The medialregion 150 is a partially cylindrical region externally shaped tocorrespond to the internal channel 125 of the first elongated member120. The rubber washer 151 and nut 143 provide a compression typecoupling scheme between the tension members 210 and the second elongatedmember 140. In an assembled configuration (not shown), the tensionmembers 210 extend along grooves 154 in the threaded region 152 and arecompression coupled to the medial region via the rubber washer 151 andthe nut 143. It will be appreciated that other types of coupling systemsmay be utilized between the tension members 210 and the second elongatedmember 140. The shaft 156 includes a non-circular cross-sectional shapeso as to facilitate rotational binding with the remainder of the secondelongated member 140. The illustrated shaft 156 is square shaped anddisposed within a corresponding square recess within the threaded region152 so as to enable rotational coordination between the proximal end 142and the distal end 160 of the second elongated member 140. The proximalend of the shaft 156 is releasably disposed and/or coupled within thesquare recess of the threaded region 152. This configuration enableslengthwise translational separation between the shaft 156 and thethreaded region 152 as the second elongated member 140 is proximallytranslated with respect to the first elongated member 120. The distalend 160 is directly coupled to the shaft 156 via a welding or adhesivetype coupling. The distal end 160 may also be referred to as a lockingmember in that it functions to selectively lock the articulation freedomof the proximal segment 182 of the arm members 180. The distal end 160of the second elongated member 140 includes the illustrated threadedmale region that couples within a corresponding female threaded regionon the distal end 130 of the first elongated member 120. Thecorresponding coupling between the threaded regions obstructstranslational freedom but enables rotational freedom between the distalends 130, 160 of the first and second elongated members 120, 140. Thedistal end 160 includes a plurality of radial channels 162 and radialstops 164. In an operational configuration, the shaft 156 is sized androuted through the internal channel 125 of the first elongated member120 such that the distal end 160 is exposed and positioned furtherdistal of the distal end 130 of the first elongated member 120 asillustrated in FIG. 3.

Reference is next made to FIG. 3, which illustrates a detailed assembledperspective view of the distal ends 130, 160 of the first and secondelongated members 120, 140, the arm members 180, and the tension members210 of the hernia repair system 100. The distal end 160 of the secondelongated member 140 is distally positioned to geometrically cap thedistal end 130 of the first elongated member 120. The geometric cappingconfiguration includes aligning the radial curvatures and diameters ofthe distal ends 130, 160. In addition, the radial relative position ofthe distal ends 130, 160 with respect to one another corresponds to thearticulation freedom of the arm members 180. In the illustratedconfiguration, the arm members 180 are distally extended from the armarticulation regions 132 of the first elongated member 120 through theradial channels 162 of the second elongated member 140. Therefore, theradial channels 162 of the second elongated member 140 are rotationallyaligned with the arm articulation regions 132 of the first elongatedmembers 120, thereby allowing the arm members 180 to articulatedistally. As will be discussed in more detail below, the operation ofthe system 100 includes the ability for a user to rotate the secondelongated member 140 with respect to the first elongated member 120,thereby rotating the radial orientations of the distal ends 130, 160with respect to one another. The illustrated rotational orientation ofthe distal ends 130, 160 with respect to one another may be referred toas an unrestricted configuration because of the rotational alignmentbetween the radial channels 162 and arm articulation region 132.

Reference is next made to FIG. 4, which illustrates a detailed assembledperspective view of the distal ends 130, 160 of the first and secondelongated members 120, 140, the arm members 180, and the tension members210 of the hernia repair system 100. FIG. 4 particularly illustrates thecomplete length of the arm members 180 including the proximal segment182, medial segments 184, and distal segment 190. One of the arm members180 is proximally lengthwise articulated including a combinedarticulation of individual segments 182, 184, 190, and an articulationwith respect to the distal end 130 of the first elongated member 120.The illustrated segments 182, 184, 190 are intercoupled utilizing a maleto female portion intercoupled with a pin 186. The particular moveablecoupling scheme between the segments 182, 184, 190 will be furtherdescribed with reference to FIG. 6. The tension members 210 extendlengthwise along the proximal and medial segments 182, 182 to the distalsegment 190. The lengthwise side of the segments 182, 184, 190 alongwhich the tension members 210 extend may be described as either theinward side or distal side due to the moveable positioning of the armmembers 180.

Reference is next made to FIGS. 5A-5F, which illustrate cross-sectionalviews of the hernia repair system of FIG. 1 along the corresponding axisdesignations A-A′ through F-F′. FIG. 5A illustrates the medial region150 of the second elongated member 140 disposed within the cylindricalregion 125 of the first elongated member 120. The medial region 150 isspecifically sized and shaped to facilitate translation within theinternal channel 126 of the first elongated member 120. FIG. 5Billustrates the shaft 156 positioned within the threaded region 152 ofthe second elongated member 140 and the cylindrical region 150 of thefirst elongated member 120. In addition, the tension members 210 arerouted through the grooves 154 of the threaded region 152. The tensionmembers 210 are circumscribed and compression coupled to the threadedregion 152 by the nut 143. The nut 143 is correspondingly internallythreaded to couple over the threaded region 152. FIG. 5C illustrates thetension members 210 lengthwise extending along the shaft 156 within thecylindrical region 124 of the first elongated member 120. FIG. 5Dillustrates the arm articulation regions 132, spacer regions 134, androtational regions 136 of the distal end 130 of the first elongatedmember 120. The rotational regions 136 provide a groove that extendscircumferentially around the entire distal end 130 which enables thelocked configuration of the distal ends 130, 160, described in furtherdetail below with reference to FIG. 11. The distal end 160 of the secondelongated member 140 is illustrated as extending within the center ofthe distal end 130 of the first elongated member 120. In addition, thetension members 210 are routed radially external to the distal end 130of the first elongated member 130. FIG. 5E illustrates the channels 162and stops 164 of the distal end 160 of the second elongated member 140.Likewise, the tension members 210 are routed radially external to thedistal end 160 of the second elongated member 140. FIG. 5F illustratesthe orientations of the medial segments 184 of the arm members 180 withrespect to the tension members 210.

Reference is next made to FIG. 6, which illustrates a detailedperspective view of the distal segment 190 of a single arm member of thehernia repair system 100. The intercoupling between the medial segment184 and the distal segment 190 is representative of the intercouplingscheme utilized between the other segments. The distal segment 190includes segment portion 189 with a female region 187 disposed oppositeto the distal most end. A corresponding male portion 188 of the medialsegment 184 is positioned within the female region 187 of the segmentportion 189 and coupled via a pin 186. The pin 186 enables a rotationalarticulation between the medial segments 184 and segment portion 189 ofthe distal segment 190. In addition, the shape of the male and femaleregions 188, 187 restrict the relative rotational articulation. Thefemale region 187 includes a lengthwise recess only exposed on onelengthwise side (illustrated upward) of the segment portion 187.Therefore, the opposite side of the segment portion 189 is covered,restricting the male region 188 from rotationally articulating in onedirection beyond a substantially lengthwise parallel configuration. Themale region 188 therefore is only able to rotate within a substantiallyninety degrees of freedom with respect to the female region 187. Thedistal segment 190 further includes a needle retaining member 192moveably coupled to the segment portion 189 via a pin 186 on an oppositelengthwise side of the medial segment 184. The needle retaining member192 includes two recesses 196, 197 for releasably housing a first andsecond needle 198, 199 respectively. In addition, the tension members210 are rigidly coupled to the needle retaining member 192 via a tab194. The moveable coupling of the needle retaining member 192 enables asubstantially ninety degree rotational freedom of the needle retainingmember 192 with respect to the segment portion 189. As will be describedin further detail below, the articulation position of the needleretaining member 192 with respect to the segment portion 189 isdetermined in part by the tension on the tension member 210. The needles198, 199 are coupled to a first and second suture 201, 202 to facilitatecoupling the mesh (not shown) over the distal side of a herniatedregion.

Reference is next made to FIG. 7, which illustrates a profile view ofthe proximal ends 122, 142 of the first and second elongated member 120,140 of the hernia repair system 100 in an assembled configuration. Theoperation of the system 100 is controlled by the relative positioning ofthe proximal ends 122, 142 to enable a user to externally manipulate thedistal ends 130, 160 without unnecessarily invasively exposing thesurgical region. The proximal end 142 is coupled to the square region146 of the second elongated member 140 via the locking pin 144. Theshape of the square region 146 corresponds to proximal opening to theinternal region 126 on the proximal end 122 of the first elongatedmember 120. The proximal end 122 is coupled to the cylindrical region124.

Reference is next made to FIG. 8, which illustrates a detailedperspective view of the mesh 205 coupled to the distal side of the armmembers 180 in a radially extended configuration of the hernia repairsystem 100. The mesh 205 is a flexible material designed to cover thehernia defect in a two dimensional fashion. Various well known mesh orimplant type materials may be utilized in accordance with embodiments ofthe present invention. The mesh 205 includes two sutures 201, 202 whichextend across and around the distal side (not shown) of the mesh 205 tofacilitate suturing. The sutures 201, 202 may also be any type ofconvention sutures in accordance with embodiments of the presentinvention. The sutures 201, 202 are coupled to the lengthwise end of theneedles 198, 199 disposed within the recesses of the needle retainingmember 192. The needle retaining member 192 is oriented with respect tothe segment portion 189 and the arm members 180 such that the needles198, 199 are oriented perpendicular to the mesh 205 to enable routingthe needles 198, 199 through the edges of the hernia defect. As will bediscussed in more detail below, the specific positions of the needleretaining member 192 and overall lengthwise configuration of the armmembers 180 corresponds to the tension of the tension members 210 andthe relative positioning of the proximal ends 122, 142 of the first andsecond elongated member 120, 140.

Reference is next made to FIGS. 9A-9B, which illustrate perspectiveviews of the proximal ends 122, 142 of the first and second elongatedmember 120, 140 corresponding to two different operational states of thehernia repair system 100. FIG. 9A illustrates an unlocked in which theproximal ends 122, 142 are rotationally aligned with one another. Theunlocked configuration corresponds to the distal end 160 of the secondelongated member 140 being rotationally aligned with the distal end 130of the first elongated member 120 to enable distal articulation of thearm members 180, as illustrated in FIGS. 3 and 4. In addition, theproximal ends 122, 142 are translationally disposed adjacent to oneanother in the unlocked or distal freedom configuration such that thedistal-most region of the second elongated member 140 proximal end 142is adjacent to the proximal-most region of the first elongated member120 proximal end 122. As described above, the unlocked configurationcorresponds to a particular rotational alignment of the distal ends 130,160 to enable distal articulation of the arm members 180. The particularconfiguration of the proximal ends 122, 142 may also be referred to as adistal freedom configuration because the arm members 180 are enabled tolengthwise articulate freely between the radial extended and distallengthwise extended configurations. Operationally, the system 100 isinitially inserted through a trocar with the proximal ends 122, 142 inthe unlocked configuration (FIG. 9A) to enable a particular unlockedrotational alignment of the distal ends 160, 130 (FIG. 10) and the armmembers 180 to be positioned within a distal extended configuration(FIG. 12) that is capable of being contained within the diameter of theinternal channel of the trocar. As will be described further below inreference to FIG. 10, the tension members 210 are sized and positionedso as to have little or no tension in the unlocked configuration of theproximal ends 122, 142. Therefore, the tension members 210 do not exertany substantial tension forces affecting the articulation position ofthe arm members 180 in the unlocked configuration.

FIG. 9B illustrates the locked configuration in which the proximal ends122, 142 are translationally separated and rotated with respect to oneanother. The second elongated member 140 proximal end 142 is retractedor translated proximally away from the first elongated member 120proximal end 122, causing the flat region 146 to extend a particulardistance through the proximal opening to the internal channel 126 suchthat the notch 148 is translationally aligned with the proximal opening.The notch 148 of the second elongated member 140 enables the secondelongated member 140 to be rotated with respect to the first elongatedmember 120 within the flat shaped proximal opening of the firstelongated member 120. The rotation of the proximal end 142 of the secondelongated member 140 corresponds to a rotation of the distal end 160.The direction and degree of rotation between the proximal ends 142, 122may be determined by the shape of the notch 148. The notch 148 may bespecifically shaped to limit the rotation of the second elongated member140 to ensure accurate rotational positioning of the distal end 160 ofthe second elongated member 140 with respect to the distal end 130 ofthe first elongated member 120. The illustrated extended and rotationalposition of the proximal ends 142, 122 corresponds to both tensioningthe tension members 210 and rotating the distal end 160 of the secondelongated member 140 with respect to the first elongated member 120.Operationally, the proximal ends 122, 142 are subsequently manipulatedby a user into the locked configuration (FIG. 9B) to enable a particularlocked rotational alignment of the distal ends 160, 130 (FIG. 11) thatlocks the arm members 180 into a radial extended configuration (FIG.13). The radial extended configuration of the system 100 is capable ofattaching and suturing the mesh over the herniated region. Since thetension members 210 are rigidly coupled to both the first and secondelongated members 120, 140, the relative extension or translation causesa tension force in the tension members 210 which will be describedfurther below with reference to FIGS. 11 and 13.

Reference is next made to FIG. 10, which illustrates a detailedperspective view of the distal ends 130, 160 of the first and secondelongated members 120, 140 in an unlocked configuration of the herniarepair system 100. The unlocked configuration of the distal ends 130,160 corresponds to a rotational alignment of the channels 162 with thearm articulation regions 132. Likewise, the stops 162 are rotationallyaligned with the spacer regions 134. Because of the adjacent positioningof the proximal ends 122, 142 (FIG. 9A), the tension members 210 are nottensioned and therefore do not exert any substantial forces upon the armmembers 180 in this configuration. The positioning of the distal ends160, 130 enables the proximal segments 182 of the arm members 180 toarticulate within an approximate ninety degree freedom between aperpendicular (shown) position and a substantially parallel lengthwiseposition. The proximal segments 182, articulate lengthwise within thearticulation regions 132 and channels 162 of the distal ends 130, 160respectively.

Reference is next made to FIG. 11, which illustrates a detailedperspective view of the distal ends 130, 160 of the first and secondelongated members 120, 140 in a locked configuration of the herniarepair system 100. The second elongated member 140 distal end 160 isrotated with respect to the first elongated member 130 distal end 130such that the stops 164 are rotationally aligned with the arm members180 and the arm articulation regions 132. The relative rotationalpositioning of the distal ends 130, 160 locks or substantially restrictsthe articulation freedom of the proximal segment 182 of the arm members180 into the illustrated radial or perpendicular configuration withrespect to the first elongated member 120. Because of the correspondingseparation of the proximal ends 122, 142 (FIG. 9B), the tension members210 become taut and exert a radially-oriented tension force upon the armmembers 180 and effectively restrict the medial and distal segments 184,190 into the radially extended configuration FIG. 13).

Reference is next made to FIG. 12, which illustrates a detailedperspective view of the arm members 180, mesh 205, and the distal ends160, 130 of the first and second elongated members 120, 140 in a distallengthwise extended configuration of the arm members 180 of the herniarepair system 100. The lengthwise extended configuration of the armmembers 180 corresponds to the unlocked configurations of the distal andproximal ends 130, 160, 122, 142 of the first and second elongatedmembers 120, 140. The arm members 180 extend substantially lengthwiseaway from the distal ends 130, 160 in a distal direction. The mesh 205is disposed between the arm members 180. The arm members 180 aresubstantially lengthwise aligned including lengthwise alignment of theproximal, medial, and distal segments 182, 184, 190. However, theunlocked configuration of the distal and proximal ends 130, 160, 122,142 of the first and second elongated members 120, 140 corresponds toarticulation freedom of the arm members 180, and therefore they are notlocked into the lengthwise extended configuration. Likewise, the tensionmembers 210 are not taut and do not exert any form of tension force uponthe arm members 180 into the lengthwise extended configuration. Themale-female pin type coupling described in detail with reference to FIG.6, between the segments 182, 184, 190 prevents the inward articulationof the arm members 180 beyond the lengthwise extended configuration. Thepin retaining members 192 are illustrated in a radial orientedconfiguration but are capable of articulating such that the needles (notshown) are proximally oriented and lengthwise folded against thecorresponding arm members 180. Therefore, as the system 100 isoperationally initially inserted into a trocar, the needles (not shown)extending from the needle retaining members 192 will be forced toarticulate proximally to enable lengthwise alignment and systemcontainment within the trocar channel.

Reference is next made to FIG. 13, which illustrates a detailedperspective view of the arm members 180, mesh 205, and the distal ends130, 160 of the first and second elongated members 120, 140 in aradially extended configuration of the arm members 180 of the herniarepair system 100. The radially extended configuration of the armmembers 180 corresponds to the locked configurations of the distal andproximal ends 130, 160, 122, 142 of the first and second elongatedmembers 120, 140. The arm members 180 are radially extendedsubstantially perpendicular to the first and second elongated members120, 140. The corresponding locked configuration of the proximal ends122, 142 causes the tension members 210 to be taut, thereby exerting atension force across the arm members 180. Because of the routingconfiguration of the tension members 210, this causes the arm members180 to be radially extended with respect to the distal ends 130, 160.The mesh 205 is positioned on the distal side of the arm members 180.The tension members 210 are directly coupled to the needle retainingmembers 192, and therefore the tension force also causes the needleretaining members 192 to orient the needles proximally substantiallyperpendicular to the arm members 180. In operation, the arm members 180are extended into the radial extended configuration upon being disposeddistal of the herniated region such that the mesh 205 may beappropriately positioned on the distal side of the entire herniatedregion. The orientation of the needles 201, 202 enables a user to thenretract the entire system and cause the needles to pierce the fascialedges around the herniated region to enable external suturing of themesh 205 over the herniated region.

Reference is next made to FIG. 14, which illustrates a detailedperspective view of the arm members 180 and the distal ends 130, 160 ofthe first and second elongated members 120, 140 in a partially retractedconfiguration of the hernia repair system 100. The illustrated partiallyretracted configuration corresponds to the unlocked configurations ofthe distal and proximal ends 130, 160, 122, 142 of the first and secondelongated members 120, 140. The arm members 180 are illustrated in apartially articulated configuration representing the process throughwhich the arm members 180 are retracted from between the herniatedregion and the mesh 205. The articulation freedom of the arm members inthe unlocked configurations enables the individual segments 182, 184,190 of each arm member to articulate proximally lengthwise to correspondto the extraction position. Therefore, the arm members 180 may beretracted from a narrow region contained between the mesh 205 and thehernia.

In operation, systems in accordance with the present invention may beutilized to insert and attach a mesh over the distal side of a herniatedregion via the herniated opening itself. A trocar is positioned throughthe herniated opening so as to provide a proximal to distal channelextending externally to internally. Initially, the system 100 is in theunlocked configurations (FIG. 9A and 10) of the distal and proximal ends130, 160, 122, 142 of the first and second elongated members 120, 140,including a substantially distal extended configuration of the armmembers 180 (FIG. 13). The system 100 is initially translationallydistally inserted by a user through the internal channel of a trocaruntil the arm members 180 and distal ends 130, 160 are distal to thehernia. An optional telescoping sleeve may be utilized to contain thearm members 180 within the distal extended configuration (FIG. 12)during insertion. The optional sleeve may then be automatically ormanually telescopically retracted proximally from the arm members 180and distal ends 130, 160 once the arm members 180 and distal ends 130,160 are distally disposed with respect to the hernia. The user may thenproximally retract and subsequently rotate the second elongated member140 proximal end 142 from the first elongated member 120 proximal end122 causing engagement of the locked configurations (FIGS. 9B and 11)and substantial locking of the arm members 180 into the radial extendedconfiguration (FIG. 14). The user may then proximally translate theentire system 100 so as to extend the needles 198, 199 through theabdominal wall around the herniated region and position the mesh 205over the distal side of the herniated region. The needles may then beexternally interwoven to suture the mesh 205. Various needle releasesystems may be utilized to release the needles from the needle retainingmembers. The user may then oppositely rotate and subsequently distallytranslate the second elongated member 140 proximal end 142 with respectto the first elongated member 120 proximal end 122, disengaging thelocked configurations into the unlocked configurations (FIG. 9A and 10)of the distal and proximal ends 130, 160, 122, 142 of the first andsecond elongated members 120, 140. The reverse rotation is orientedopposite to the rotation used to engage the locked configurations. Theunlocked configurations enable the segments 182, 184, 190 of the armmembers 180 to independently articulate within a lengthwise proximalorientation. The user then proximally retracts the system 100 frombetween the mesh 205 and the herniated region. As the segments 182, 184,190 translate into the internal channel of the trocar, they are forcedto individually articulate by varying degrees to enable the retraction.The arm members 180 are thereby proximally lengthwise articulated fromthe radial extended configuration back to the lengthwise distal extendedconfiguration over the course of the retraction process.

Various other embodiments have been contemplated, including combinationsin whole or in part of the embodiments described above. Variousadditional components and or materials may be used in conjunction withembodiments of the present invention.

What is claimed is:
 1. A hernia repair system comprising: a firstelongated member having a distal end, a proximal end, and an internalchannel extending therebetween, wherein the distal end includes a distalopening to the internal channel and the proximal end includes a proximalopening to the internal channel; a second elongated member extendingthrough the internal channel of the first elongated member, wherein thesecond elongated member includes a locking member disposed on a distalend; a plurality of arm members moveably coupled to the distal end ofthe first elongated member, wherein the arm members each comprise aplurality of moveably intercoupled segments, wherein the moveablecoupling of the arm members to the first elongated member is restrictedto limit the articulation of the arm members between a lengthwiseextended distal configuration and a radial extended configuration, andwherein the arm members further include a distal segment disposed on alengthwise end of each arm member opposite the moveable coupling withthe first elongated member; a plurality of tension members rigidlycoupled to and extending between the distal segment of each of theplurality of arm members and the second elongated member, wherein thetension of the plurality of tension members corresponds to theconfiguration of the plurality of arm members, and wherein the pluralityof tension members extend substantially adjacent to the plurality ofsegments and through the internal channel of the first elongated member;wherein the radial extended configuration includes a proximaltranslational displacement of the second elongated member with respectto the first elongated member, a tension in the plurality of tensionmembers, and a radial extended position of the plurality of arm memberssubstantially perpendicular to the first elongated member; and a meshreleasably coupled to a distal side of the plurality of arm members inthe radial extended configuration.
 2. The hernia repair system of claim1, wherein the moveable intercoupling between the segments is restrictedto within a ninety degree lengthwise radial articulation.
 3. The herniarepair system of claim 1, wherein the moveably intercoupled segmentscomprise: a rectangular body with a first and second end; a hoodedfemale region disposed on the first end; and a male region disposed onthe second end, wherein the male region is configured to be disposedwithin the hooded female region of an adjacent segment and wherein a pinis perpendicularly extended through the male segment and the adjacenthooded female segment creating the moveable intercoupling therebetween.4. The hernia repair system of claim 3, wherein the moveableintercoupling between the male and female regions of adjacent segmentsenables a lengthwise articulation about the pin, and wherein a hoodedportion of the female region restricts the lengthwise articulation anglebetween the segments to substantially ninety degrees of lengthwisearticulation.
 5. The hernia repair system of claim 1, wherein theindividual moveable coupling of the arm members to the first elongatedmember is restricted to within a ninety degree lengthwise radialarticulation.
 6. The hernia repair system of claim 1, wherein the distalsegment of each arm member includes a needle retaining member and atleast one needle, and wherein the needle is releasably coupled to theneedle retaining member and the mesh.
 7. The hernia repair system ofclaim 1, wherein the lengthwise extended distal configuration includesthe plurality of arm members lengthwise distally extended substantiallyparallel with the first elongated member.
 8. The hernia repair system ofclaim 1, wherein the distal end of the second elongated member includesa locking member comprising a plurality of radial channels and radialstops, wherein the radial extended configuration includes alignment ofthe radial stops with the plurality of arm members thereby restrictingthe plurality of arm members from distally lengthwise extending beyondthe substantially perpendicular orientation with respect to the firstelongated member.
 9. The hernia repair system of claim 1, wherein thedistal segments of each arm member include a needle retaining member,and wherein the needle retaining members releasably support a pluralityof suture needles intercoupled to one another and the mesh, and whereinthe coupling between the needle retaining members and the arm members isconfigured such that the suture needles are proximally oriented parallelto the first elongated member in the radial extended configuration andthe distal lengthwise configuration.
 10. The hernia repair system ofclaim 1, wherein the number of segments included in each arm member andthe orientation of the moveable intercoupling between the segmentscorresponds to the lengthwise articulation freedom of each arm member.11. The hernia repair system of claim 1, wherein proximal end of thefirst elongated member includes a finger handle, and wherein theproximal end of the second elongated member includes a thumb handle. 12.The hernia repair system of claim 1, wherein the radial extendedconfiguration further includes a locked configuration and an unlockedconfiguration, wherein the locked configuration corresponds to arotational position of the distal end of the second elongated memberthat restricts the plurality of arm members from distally lengthwiseextending beyond the substantially perpendicular orientation withrespect to the first elongated member.
 13. The hernia repair system ofclaim 12, wherein each arm member includes a proximal segment at whichthe arm member is moveably coupled to the first elongated member,wherein the rotational position of the distal end of the secondelongated member in the locked configuration substantially restricts allmovement freedom of the proximal segment.
 14. The hernia repair systemof claim 1, wherein the system is particularly configured for at leastone of a ventral, incisional, and umbilical hernia repair.
 15. Thehernia repair system of claim 1, wherein the lengthwise extended distalconfiguration further includes a deployment sub-configuration and aretraction sub-configuration corresponding to the deployment andretraction phases of the corresponding operative procedure, and whereinthe deployment sub-configuration includes the mesh disposed within thethree dimensional region between the arm members.
 16. The hernia repairsystem of claim 1, wherein the mesh is releasably coupled to a needleretaining member of the plurality of arm members.
 17. A self-containedventral hernia repair system comprising: a first elongated member havinga distal end, a proximal end, and an internal channel extendingtherebetween, wherein the distal end includes a distal opening to theinternal channel and the proximal end includes a proximal opening to theinternal channel; a second elongated member extending through theinternal channel of the first elongated member, wherein the secondelongated member includes a locking member disposed on a distal end; aplurality of arm members moveably coupled to the distal end of the firstelongated member, wherein the arm members each comprise a plurality ofmoveably intercoupled segments, wherein the moveable intercouplingbetween the segments is restricted to within a ninety degree lengthwiseradial articulation, and wherein the moveable coupling of the armmembers to the first elongated member and the moveable intercouplingbetween the segments is restricted to articulate between a lengthwiseextended distal configuration and a radial extended configuration,wherein the arm members further include a needle retaining membermoveably coupled to the distal most segment of each arm member; aplurality of tension members rigidly coupled to and extending betweenthe needle retaining member of each of the plurality of arm members andthe second elongated member, wherein the tension of the plurality oftension members corresponds to the configuration of the plurality of armmembers, and wherein the plurality of tension members extendsubstantially adjacent to the plurality of segments and through theinternal channel of the first elongated member external to the secondelongated member; wherein the radial extended configuration includes aproximal translational displacement of the second elongated member withrespect to the first elongated member, a tension in the plurality oftension members, and a radial extended position of the plurality of armmembers substantially perpendicular to the first elongated member;wherein the lengthwise extended distal configuration includes theplurality of arm members lengthwise extended such that the needleretaining member is disposed distal of the distal end of the firstelongated member; and a mesh releasably coupled to a distal side of theplurality of arm members in the radial extended configuration.
 18. Amethod for distally coupling a mesh over a ventral hernia in theabdominal wall and subsequently removing the remainder of the herniarepair system, comprising the acts of: providing a trocar extendingthrough a hernia in the abdominal wall of a patient including aninternal channel extending between a proximal end of the trocar disposedexternal to the patient and a distal end of the trocar disposed distalof the hernia; providing a hernia repair system comprising: a firstelongated member having a distal end, a proximal end, and an internalchannel extending therebetween, wherein the distal end includes a distalopening to the internal channel and the proximal end includes a proximalopening to the internal channel; a second elongated member extendingthrough the internal channel of the first elongated member, wherein thesecond elongated member includes a locking member disposed on a distalend; a plurality of arm members moveably coupled to the distal end ofthe first elongated member, wherein the arm members each comprise aplurality of moveably intercoupled segments, and wherein the arm membersfurther include a distal segment disposed on a lengthwise end of eacharm member opposite the moveable coupling with the first elongatedmember; a plurality of tension members rigidly coupled to and extendingbetween the distal segment of each arm member and the second elongatedmember; a mesh releasably coupled to a distal side of the plurality ofarm members in the radial extended configuration; inserting the herniarepair system through the internal channel of the trocar such that theplurality of arm members are distal of the trocar; radially extendingthe arm members substantially perpendicular to the first elongatedmember; coupling the mesh over a distal opening to the hernia andreleasing the mesh from the plurality of arm members; and retracting thearm members from between the mesh and hernia into the internal channelof the trocar; and retracting the hernia repair system from the internalchannel of the trocar.
 19. The method of claim 18, wherein the act ofradially extending the arm members substantially perpendicular to thefirst elongated member comprises: proximally translating the secondelongated member from the first elongated member thereby inducing atension on the tension members; tensioning the moveably intercoupledsegments of each arm member substantially parallel; tensioning each armmember into a radial extended configuration in which the lengthwiseorientation of each arm member is substantially perpendicular withrespect to the first elongated member; rotating the second elongatedmember with respect to the first elongated member locking the armmembers in the radial extended configuration.
 20. The method of claim18, wherein the act of coupling the mesh over a distal opening to thehernia and releasing the mesh from the plurality of arm members furthercomprises: proximally partially retracting the first and secondelongated member; extending a plurality of interwoven needles disposedon the distal segment of each arm member through the abdominal wall. 21.The method of claim 18, wherein the act of retracting the arm membersfrom between the mesh and hernia into the internal channel of the trocarincludes individually articulating the moveably intercoupled segmentsfrom one another enabling corresponding lengthwise proximal orientedarticulation of each of the arm members.
 22. The method of claim 21,wherein the act of individually articulating the moveably intercoupledsegments includes progressively articulating the segments with respectto the proximity to the hernia.